Anne Rydall

Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial

BACKGROUND Patients with advanced cancer have reduced quality of life, which tends to worsen towards the end of life. We assessed the effect of early palliative care in patients with advanced cancer on several aspects of quality of life. METHODS The study took place at the Princess Margaret Cancer Centre (Toronto, ON, Canada), between Dec 1, 2006, and Feb 28, 2011. 24 medical oncology clinics were cluster randomised (in a 1:1 ratio, using a computer-generated sequence, stratified by clinic size and tumour site [four lung, eight gastrointestinal, four genitourinary, six breast, two gynaecological]), to consultation and follow-up (at least monthly) by a palliative care team or to standard cancer care. Complete masking of interventions was not possible; however, patients provided written informed consent to participate in their own study group, without being informed of the existence of another group. Eligible patients had advanced cancer, European Cooperative Oncology Group performance status of 0-2, and a clinical prognosis of 6-24 months. Quality of life (Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being [FACIT-Sp] scale and Quality of Life at the End of Life [QUAL-E] scale), symptom severity (Edmonton Symptom Assessment System [ESAS]), satisfaction with care (FAMCARE-P16), and problems with medical interactions (Cancer Rehabilitation Evaluation System Medical Interaction Subscale [CARES-MIS]) were measured at baseline and monthly for 4 months. The primary outcome was change score for FACIT-Sp at 3 months. Secondary endpoints included change score for FACIT-Sp at 4 months and change scores for other scales at 3 and 4 months. This trial is registered with ClinicalTrials.gov, number NCT01248624. FINDINGS 461 patients completed baseline measures (228 intervention, 233 control); 393 completed at least one follow-up assessment. At 3-months, there was a non-significant difference in change score for FACIT-Sp between intervention and control groups (3·56 points [95% CI -0·27 to 7·40], p=0·07), a significant difference in QUAL-E (2·25 [0·01 to 4·49], p=0·05) and FAMCARE-P16 (3·79 [1·74 to 5·85], p=0·0003), and no difference in ESAS (-1·70 [-5·26 to 1·87], p=0·33) or CARES-MIS (-0·66 [-2·25 to 0·94], p=0·40). At 4 months, there were significant differences in change scores for all outcomes except CARES-MIS. All differences favoured the intervention group. INTERPRETATION Although the difference in quality of life was non-significant at the primary endpoint, this trial shows promising findings that support early palliative care for patients with advanced cancer. FUNDING Canadian Cancer Society, Ontario Ministry of Health and Long Term Care.

Disordered Eating Behavior and Microvascular Complications in Young Women with Insulin-Dependent Diabetes Mellitus

BACKGROUND Insulin-dependent diabetes mellitus (IDDM) and eating disorders are relatively common among young women in North America. Their coexistence could lead to poor metabolic control and an increased risk of the microvascular complications of IDDM. METHODS We studied 91 young women with IDDM at base line and four to five years later to determine the prevalence and persistence of disordered eating behavior (on the basis of self-reported eating and weight-loss practices, including the intentional omission or underdosing of insulin to control weight) and the association of such eating disorders with metabolic control, diabetic retinopathy, and urinary albumin excretion. At base line, the mean age of the young women was 15+/-2 years and the duration of diabetes was 7+/-4 years. RESULTS At base line, 26 of 91 young women (29 percent) had highly or moderately disordered eating behavior, which persisted in 16 (18 percent) and improved in 10 (11 percent). Of the 65 women with normal eating behavior at base line (71 percent), 14 (15 percent) had disordered eating at follow-up. Omission or underdosing of insulin lose weight was reported by 12 of 88 young women (14 percent) at base line and 30 (34 percent) at follow-up (P=0.003). At base line, the mean (+/-SD) hemoglobin A(1c) value was higher in the group with highly disordered eating behavior (11.1+/-1.2 percent) than in the groups whose eating behavior was moderately disordered (8.9+/-1.7 percent) or nondisordered (8.7+/-1.6 percent, P<0.001). Disordered eating at base line was associated with retinopathy four years later (P=0.004), when 86 percent of the young women with highly disordered eating behavior, 43 percent of those with moderately disordered eating behavior, and 24 percent of those with nondisordered eating behavior had retinopathy. CONCLUSIONS Disordered eating behavior is common and persistent in young women with IDDM and is associated with impaired metabolic control and a higher risk of diabetic retinopathy.

Relationship of Self-efficacy and Binging to Adherence to Diabetes Regimen Among Adolescents

Objective –To test the hypothesis that poorer adherence to diabetes care is related to four variables associated with self-concept in adolescents with diabetes: self-esteem, self-efficacy, depression, and binging behavior. In addition, we expected adolescent females to be less adherent to diabetes care. Research Design and Methods –We recruited 193 consecutive patients (aged 13–18 yr) with insulin-dependent diabetes mellitus during their regular quarterly visit to a diabetes clinic in a large urban hospital. Participants completed the Rosenberg Self-Esteem Scale, the Childrens Depression Inventory, an assessment of the frequency of binging in the past 3 mo, and parallel forms of an adherence scale and a self-efficacy scale that were developed for use in this study. Results –Adolescents who reported lower adherence tended to report lower self-esteem (r = 0.45, P < 0.001) and self-efficacy (r = 0.57, P < 0.001), more depressive symptoms (r = −0.50, P < 0.001), more binging (r = −0.36, P < 0.001), and had higher HbA1c (r = −0.24, P < 0.001) than those with higher adherence scores. Together, the psychological variables accounted for 50% of the variance in adherence. There was no sex difference in reported binging, but, as expected, adolescent females reported less adherence overall (F[7,184] = 2.5, P = 0.018). Conclusions –Treatment adherence in adolescents with insulin-dependent diabetes mellitus is associated with behavioral and psychological variables. These findings suggest that specific behavioral and cognitive interventions could be used to improve adherence in those individuals who lack confidence in their ability to perform diabetes-related tasks.

Longitudinal Study of Depressive Symptoms in Patients With Metastatic Gastrointestinal and Lung Cancer

PURPOSE Although early intervention is increasingly advocated to prevent and relieve distress in patients with metastatic cancer, the risk factors for such symptoms and their trajectory are not well established. We therefore conducted a longitudinal study to determine the course and predictors of depressive symptoms. PATIENTS AND METHODS Patients (N = 365) with metastatic gastrointestinal or lung cancer completed measures of physical distress, self-esteem, attachment security, spiritual well-being, social support, hopelessness, and depression at baseline; physical distress, social support, hopelessness, and depression were subsequently assessed at 2-month intervals. RESULTS Of the sample, 35% reported at least mild depressive symptoms, with 16% reporting moderate to severe depressive symptoms that persisted in at least one third of such individuals. Moderate to severe depressive symptoms were almost three times more common in the final 3 months of life than > or = 1 year before death. Predictors of depressive symptoms included younger age, antidepressant use at baseline, lower self-esteem and spiritual well-being, and greater attachment anxiety, hopelessness, physical burden of illness, and proximity to death. The combination of greater physical suffering and psychosocial vulnerability put individuals at greatest risk for depression. CONCLUSION Depressive symptoms in advanced cancer patients are relatively common and may arise as a final common pathway of distress in response to psychosocial vulnerabilities, physical suffering, and proximity to death. These findings support the need for an integrated approach to address emotional and physical distress in this population and to determine whether early intervention may prevent depression at the end of life.

Symptomatic distress, hopelessness, and the desire for hastened death in hospitalized cancer patients

OBJECTIVE This study evaluated the desire for hastened death (DHD) in cancer patients at varying stages of disease to determine its frequency and relationship to physical and psychological distress. METHODS Two hundred twenty-four inpatients at Princess Margaret Hospital completed questionnaires assessing pain, physical symptoms, depression, hopelessness, and DHD. RESULTS There was significant physical and psychological distress in this sample with a mean of nine physical symptoms reported by each subject. Seven percent reported moderate DHD on the Schedule of Attitudes Towards Hastened Death (SAHD) and 2% reported high DHD. Hopelessness and stage of disease were the only significant independent predictors of DHD and their interaction was associated with increased DHD. Hopelessness and, less so, depression both mediated the pathways between illness-related factors and DHD. CONCLUSIONS Findings suggest that DHD is significantly related to hopelessness and advancing disease. Assessment of this phenomenon prior to the end of life may provide opportunities for intervention.

A couples intervention for patients facing advanced cancer and their spouse caregivers: outcomes of a pilot study

Objective: The primary objective of this study was to evaluate the effectiveness of a couples intervention in improving marital functioning in advanced cancer patients and their spouse caregivers. A secondary objective was to determine its impact on other symptoms of psychosocial distress and its feasibility and acceptability as a clinical intervention.

Prediction of the Onset of Disturbed Eating Behavior in Adolescent Girls With Type 1 Diabetes

OBJECTIVE—The purpose of this study was to identify predictors of the onset of disturbed eating behavior (DEB) in adolescent girls with type 1 diabetes. RESEARCH DESIGN AND METHODS—In this prospective study, participants completed the Childrens Eating Disorder Examination interview and self-report measures at baseline and at four follow-up assessments over 5 years. Participants were 126 girls with type 1 diabetes, aged 9–13 years at baseline. Of the 101 girls who did not have DEB at baseline, 45 developed DEB during the follow-up period; the 38 for whom data were available for the assessment before onset of DEB were compared with 38 age-matched girls who did not develop DEB. DEB was defined as dieting for weight control, binge eating, self-induced vomiting, or the use of diuretics, laxatives, insulin omission, or intense exercise for weight control. RESULTS—Logistic regression indicated that a model including BMI percentile, weight and shape concern, global and physical appearance-based self-worth, and depression was significantly associated with DEB onset (χ2 = 46.0, 5 d.f., P < 0.0001) and accounted for 48.2% of the variance. CONCLUSIONS—Even though scores on the measures were within the published normal range, the onset of DEB was predicted by higher depression and weight and shape concerns and lower global and physical appearance–based self-worth as well as higher BMI percentile 1–2 years earlier compared with those not developing DEB. Early interventions focused on helping girls with diabetes develop positive feelings about themselves, their weight and shape, and their physical appearance may have protective value.

Managing Cancer And Living Meaningfully (CALM): phase 2 trial of a brief individual psychotherapy for patients with advanced cancer.

Background: Advanced cancer brings substantial physical and psychosocial challenges that may contribute to emotional distress and diminish well-being. In this study, we present preliminary data concerning the effectiveness of a new brief individual psychotherapy, Managing Cancer And Living Meaningfully (CALM), designed to help individuals cope with this circumstance. Aim: To test the feasibility and preliminary effectiveness of CALM to reduce emotional distress and promote psychological well-being and growth. Design: CALM is a brief, manualized, semi-structured individual psychotherapy for patients with advanced cancer. This study employed a phase 2 intervention-only design. The primary outcome was depressive symptoms and the secondary outcomes were death anxiety, attachment security, spiritual well-being and psychological growth. These were assessed at 3 months (t1) and 6 months (t2). Multilevel regression was used to model change over time. Setting/participants: A total of 50 patients with advanced or metastatic cancer were recruited from the Princess Margaret Cancer Centre, Toronto, Canada. Results: A total of 39 patients (78%) were assessed at baseline, 24 (48%) at t1, and 16 (32%) at t2. Analyses revealed reductions over time in depressive symptoms: beta = −0.13, confidence interval (CI.95) = (−0.23, −0.022) and death anxiety: beta = −0.23, CI.95 (−0.40, −0.061); and an increase in spiritual well-being: beta = 0.14, CI.95 (0.026, 0.26). Conclusions: CALM may be a feasible intervention to benefit patients with advanced cancer. The results are encouraging, despite attrition and small effect sizes, and support further study.

Managing Cancer and Living Meaningfully (CALM): A qualitative study of a brief individual psychotherapy for individuals with advanced cancer

Background: Although psychosocial care has been regarded as central to palliative and supportive care, there have been few empirically tested approaches to individual intervention. Aim: The subjective experience of advanced cancer patients receiving a new manualized brief individual psychotherapy, referred to as Managing Cancer and Living Meaningfully (CALM), was examined prior to the initiation of a randomized controlled trial testing the effectiveness of this intervention. Design: Semi-structured interviews were conducted with patients who had a diagnosis of advanced cancer, and who underwent the intervention. Setting/Participants: Patients were recruited from a large urban regional cancer center in Toronto, Canada. The 10 interviewees included seven women and three men. All had completed between three to six CALM sessions prior to the interview. Results: The CALM intervention was associated with profound and unique patient-identified benefits and no patient-identified risks or concerns. Five interrelated benefits of the intervention were identified: (1) a safe place to process the experience of advanced cancer; (2) permission to talk about death and dying; (3) assistance in managing the illness and navigating the healthcare system; (4) resolution of relational strain; and (5) an opportunity to ‘be seen as a whole person’ within the healthcare system. These benefits were regarded by participants as unique in their cancer journey. Conclusions: Findings from a qualitative study suggest that the CALM intervention provides substantial benefits for patients with advanced cancer prior to the end of life. Findings informed the development of a randomized controlled trial to evaluate the effectiveness of this intervention.

Symptom burden and supportive care in patients with acute leukemia.

We examined the symptoms and referral rates to specialized palliative care and psychosocial oncology services of patients with acute leukemia. The Memorial Symptom Assessment Scale (MSAS) was completed by 249 adult patients with acute leukemia. Patients reported a median of 9 physical and 2 psychological symptoms, and those with intense lack of energy, difficulty sleeping and pain were more likely to report intense worrying/sadness (P<0.001). No patients with moderate-severe pain were referred for specialized symptom control and only 13% of those with severe worrying/sadness were referred to psychiatry/psychology within one month of the assessment. Patients in this population have a substantial symptom burden; further research is needed to determine the benefit of early referral to specialized supportive care services.